Study of AHRE Burden in Patients Undergoing Bachmann Bundle Area Pacing and Left Bundle Branch Pacing. (AHRE-BLAST)

December 11, 2025 updated by: Georgios Leventopoulos, University Hospital of Patras

Study of Atrial High-Rate Episode Burden in Patients Undergoing Concurrent Bachmann Bundle Area Pacing and Left Bundle Branch Pacing , Compared With Either Left Bundle Branch Pacing or Conventional Right Ventricular Pacing.

This prospective observational study evaluates the burden of Atrial High-Rate Episodes (AHRE) in patients without a prior history of atrial fibrillation who undergo concurrent Bachmann Bundle Area Pacing (BBAP) and Left Bundle Branch Pacing (LBBP). Physiological pacing at these sites aims to improve interatrial conduction and reduce the risk of atrial arrhythmias.

The study includes a comparative assessment across three patient groups:

  1. BBAP + LBBP (physiological pacing group)
  2. Right Atrial Appendage (RAA) pacing + LBBP
  3. Conventional pacing - RAA and Right Ventricular (RV) pacing AHRE burden will be quantified via device diagnostics and remote monitoring at 3, 12 and 24 months post-implantation. Episodes will be classified by duration (0-6 min, 6-24 h, >24 h), differentiating subclinical AHRE from clinically documented AF.

Secondary analyses include electrocardiographic changes (P-wave indices), the need for antiarrhythmic therapy, and comprehensive echocardiographic evaluation of atrial function (e.g., LA strain, conduction delays, LAVI).

The study aims to determine whether physiological pacing (BBAP + LBBP) provides superior protection against AHRE development compared with RAA + LBBP and conventional pacing strategies.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Atrial high-rate episodes (AHRE) detected by cardiac implantable devices are associated with an increased risk of developing atrial fibrillation (AF), stroke, and atrial remodeling. Traditional right atrial and right ventricular pacing may alter atrial activation patterns, potentially promoting electrical and structural changes that predispose to atrial arrhythmias.

Physiologic pacing strategies targeting the Bachmann bundle region and the left bundle branch have emerged as alternatives designed to preserve normal conduction pathways. Bachmann Bundle Area Pacing (BBAP) facilitates more synchronous biatrial activation, while Left Bundle Branch Pacing (LBBP) results in near-physiologic ventricular activation. Both methods may reduce conduction delays and improve atrial and ventricular electromechanical function.

This prospective observational study examines whether physiologic atrial and ventricular pacing reduces the burden of device-detected AHRE compared with commonly used pacing configurations. Three groups are evaluated: (1) BBAP combined with LBBP, (2) right atrial appendage pacing combined with LBBP, and (3) conventional right atrial and right ventricular pacing. All enrolled participants have a clinical indication for permanent pacing and no prior diagnosis of AF.

AHRE burden will be assessed through routine device diagnostics and remote monitoring over a 24-month follow-up. Electrocardiographic and echocardiographic data will also be collected to explore relationships between conduction patterns, atrial function, and arrhythmia occurrence. The study aims to clarify whether preserving physiologic conduction pathways influences long-term AHRE burden and may contribute to AF prevention in paced patients.

Study Type

Observational

Enrollment (Estimated)

460

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
    • Achaia
      • Pátrai, Achaia, Greece, 26500
        • University General Hospital of Patras

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients (≥ 18 years) with a clear indication for permanent pacing, according to ESC guidelines [15] for the management of conduction disturbances (e.g. symptomatic bradycardia, complete atrioventricular block, sinus node dysfunction).

Description

Inclusion Criteria:

  • Adult patients (≥ 18 years) with a clear indication for permanent pacing, according to ESC guidelines [15] for the management of conduction disturbances (e.g. symptomatic bradycardia, complete atrioventricular block, sinus node dysfunction).
  • Sinus rhythm at the time of implantation, with no documented episodes of atrial fibrillation prior to implantation, either in the medical history or in previous recordings (ECG, Holter, telemetry).
  • Ability to be followed up for at least 24 months after implantation.
  • Provision of written informed consent to participate in the study.

Exclusion Criteria:

  • History of atrial fibrillation prior to implantation, either permanent or paroxysmal, documented on ECG, Holter, or telemetry.
  • Prior pharmacological or interventional treatment for AF (e.g. antiarrhythmic drugs, catheter ablation).
  • Inability to comply with long-term follow-up or non-adherence to follow-up visits.
  • Contraindications to pacemaker lead placement at the selected sites.
  • Participation in another study that could influence the results.
  • Previous device implantation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Concurrent BBAP + LBBP (total physiological pacing)
RAA pacing + LBBP
Conventional pacing (RAA + RV pacing)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AHRE burden
Time Frame: 24 months
PRIMARY OUTCOME MEASURE Unit of measure : percent (%) AHRE Burden (% of monitored time) Percentage of total monitored time spent in device-detected atrial high-rate episodes (AHRE), as defined by manufacturer diagnostic criteria
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of AHRE episodes (0-6 minutes )
Time Frame: 24 months
Device-detected AHRE episodes lasting 0-6 minutes. Unit of measure: Number of episodes
24 months
Number of AHRE Episodes (6 minutes-24 hours)
Time Frame: 24 months
Device-detected AHRE episodes lasting 6 minutes to 24 hours. Unit of Measure: Number of episodes
24 months
Number of AHRE Episodes (>24 hours)
Time Frame: 24 months
Device-detected AHRE episodes lasting more than 24 hours. Unit of measure: Number of episodes
24 months
Incidence of Clinically Documented Atrial Fibrillation
Time Frame: 24 months
Clinically confirmed AF episodes identified via ECG or rhythm strip. Unit of measure : number of events
24 months
Maximum P-Wave Duration
Time Frame: Baseline, 24 months
Maximum P-wave duration measured on 12-lead ECG Unit of measure : Milliseconds (ms)
Baseline, 24 months
P - wave axis
Time Frame: Baseline, 24 months
Frontal plane P-wave axis measured on 12-lead ECG Unit of Measure: Degrees
Baseline, 24 months
Initiation or Modification of Antiarrhythmic Therapy
Time Frame: Baseline, 24 months
Number of participants requiring initiation or change in antiarrhythmic. Unit of Measure: Number of participants
Baseline, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Patras

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 5, 2027

Study Completion (Estimated)

April 14, 2028

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHP-LBBP-BBP-AHRE-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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